Regulations & Standards

Standards
National and international standards continue to become important in quality systems and in meeting legal requirements. For further information on Medical Device Standards, please visit the Association for the Advancement of Medical Instrumentation (AAMI) at www.aami.org or the American Society for Testing and Materials, www.astm.org (register for customized e-mail updates at the bottom of the ASTM home page)

Please contact our Standards Committee Chair:
Mark Furney
Cincinnati, OH
513-337-8315
mfurney@eesus.jnj.com

Regulations
The FDA Medical Device Industry Coalition (FMDIC), composed of members of the Dallas district FDA staff and individuals from associations representing the medical device industry, was formed to promote communication, education, and cooperation between the regulators and the regulated industry. To further these goals, the coalition holds quarterly meetings to discuss issues of concern to the regulation of medical devices. In addition, the coalition sponsors training meetings and seminars to help educate both the FDA and the medical device industry. ASQ Biomedical Division is a proud member of this coalition. For more information, please visit www.fmdic.org.